Disposable Aspiration and Injection Needle Suppliers
Limit companies to: Worldwide USA
Compass International, Inc. | Address: 1815 14th Street NW, Rochester, Minnesota 55901, USA 
www.compass.com | Send Inquiry | Phone: +1-(800)-933-2143
FDA Registration: 2183671 Year Established: 1986 Annual Revenues: USD 1-5 Million
Products: Bipolar Forceps, Monopolar Coagulation Probes, Image-guided Surgical System Spare Parts, Disposable Biopsy Needle, Long Bi-Polar Forceps, Biopsy Arm, ...
Compass International, Inc. produces Compass(tm) commander plus+ series, which is our flagship & which seamlessly networks radiology to the treatment planning console and to the operating room. Our cy more...
www.compass.com | Send Inquiry | Phone: +1-(800)-933-2143
FDA Registration: 2183671 Year Established: 1986 Annual Revenues: USD 1-5 Million
Products: Bipolar Forceps, Monopolar Coagulation Probes, Image-guided Surgical System Spare Parts, Disposable Biopsy Needle, Long Bi-Polar Forceps, Biopsy Arm, ...
Compass International, Inc. produces Compass(tm) commander plus+ series, which is our flagship & which seamlessly networks radiology to the treatment planning console and to the operating room. Our cy more...
Scanlan International | Address: One Scanlan Plaza, St. Paul, Minnesota 55107, USA
www.scanlaninternational.com | Send Inquiry | Phone: +1-(651)-298-0997, 800-328-9458
FDA Registration: 2126670 Year Established: 1921 Annual Revenues: USD 1-5 Million Employee Count: ~30 Quality: ISO 9001, CE Certified
Products: Clamps, Scissors, Vascular Clamps (FDA Code: DXC), Micro Surgery Instruments, Scissors, Surgical Scissors, Cartilage Scissors, ...
Scanlan International designs and manufactures surgical instrumentation. Our product categories are cardiac/vascular, neurosurgical, single-use products, instrument care and custom design. Our Scanlan more...
www.scanlaninternational.com | Send Inquiry | Phone: +1-(651)-298-0997, 800-328-9458
FDA Registration: 2126670 Year Established: 1921 Annual Revenues: USD 1-5 Million Employee Count: ~30 Quality: ISO 9001, CE Certified
Products: Clamps, Scissors, Vascular Clamps (FDA Code: DXC), Micro Surgery Instruments, Scissors, Surgical Scissors, Cartilage Scissors, ...
Scanlan International designs and manufactures surgical instrumentation. Our product categories are cardiac/vascular, neurosurgical, single-use products, instrument care and custom design. Our Scanlan more...
Dutch Ophthalmic USA | Address: 10 Continental Drive, Bldg 1, Exeter, New Hampshire 03833, USA
www.dorc.nl | Send Inquiry | Phone: +1-(603)-778-6929
FDA Registration: 1222074 Quality: ISO 9001:2000, ISO 13485:2003, CE Certified
Products: Phacoemulsification Systems, Retinal Forceps, Gases, Oils, Liquids, Zenoni angled Retinal Forceps, End Gripping Retinal Forceps, Titanium RETINAL Forceps, ...
Dutch Ophthalmic USA provides ophthalmic surgeons with instruments & equipment designed specifically for the demanding needs of phacoemulsification and vitreoretinal surgery. Our products include surg more...
www.dorc.nl | Send Inquiry | Phone: +1-(603)-778-6929
FDA Registration: 1222074 Quality: ISO 9001:2000, ISO 13485:2003, CE Certified
Products: Phacoemulsification Systems, Retinal Forceps, Gases, Oils, Liquids, Zenoni angled Retinal Forceps, End Gripping Retinal Forceps, Titanium RETINAL Forceps, ...
Dutch Ophthalmic USA provides ophthalmic surgeons with instruments & equipment designed specifically for the demanding needs of phacoemulsification and vitreoretinal surgery. Our products include surg more...
Robbins Instruments, Inc. | Address: 2, North Passaic Avenue, Chatham, New Jersey 07928, USA
www.robbinsinstruments.com | Send Inquiry | Phone: +1-(800)-206-8649
FDA Registration: 2221941
Products: Dermatomes, Mucotomes, Beaver Blades, Hemostatic Mosquito Forceps, Rake Retractors, Double Prong Skin Hooks, ...
Robbins Instruments, Inc. deals with medical instruments, equipments & other accessories. We specialize in liposuction, electro-surgical devices, dermabrasion, micropigmentation and tattooing. Our sur more...
www.robbinsinstruments.com | Send Inquiry | Phone: +1-(800)-206-8649
FDA Registration: 2221941
Products: Dermatomes, Mucotomes, Beaver Blades, Hemostatic Mosquito Forceps, Rake Retractors, Double Prong Skin Hooks, ...
Robbins Instruments, Inc. deals with medical instruments, equipments & other accessories. We specialize in liposuction, electro-surgical devices, dermabrasion, micropigmentation and tattooing. Our sur more...
Becton, Dickson & Co., | Address: One Becton Drive, Franklin Lakes, New Jersey 07417, USA
www.bd.com/us | Phone: +1-(201)-847.6800
FDA Registration: 1119779 Annual Revenues: USD 10-25 Million Employee Count: ~1600 Quality: ISO 9000, CE Certified
Products: Software Programs, CCD Cameras, & Gamma Cameras, Biomedical Devices, 3D Imaging Devices, Frame Grabbers, Densitometers Accessories, ...
Becton, Dickinson & Co., manufactures and distributes a broad range of medical supplies, devices, laboratory equipment and diagnostic products. Our product BD Soluvia™ is a prefillable microinje more...
www.bd.com/us | Phone: +1-(201)-847.6800
FDA Registration: 1119779 Annual Revenues: USD 10-25 Million Employee Count: ~1600 Quality: ISO 9000, CE Certified
Products: Software Programs, CCD Cameras, & Gamma Cameras, Biomedical Devices, 3D Imaging Devices, Frame Grabbers, Densitometers Accessories, ...
Becton, Dickinson & Co., manufactures and distributes a broad range of medical supplies, devices, laboratory equipment and diagnostic products. Our product BD Soluvia™ is a prefillable microinje more...
E-Z-EM Inc. | Address: 1111 Marcus Avenue Suite LL26, Lake Success, New York 11042, USA
www.ezem.com | Send Inquiry | Phone: +1-(516)-333-8230
FDA Registration: 2411512 Year Established: 1962
Products: Gastroenterologic Needle Holder (FDA Code: FHQ), X-Ray Aids, Diagnostic Aids, Biopsy Supplies, Contrast Media, Disposable Needles, ...
E-Z-EM Inc manufactures products used for imaging the gastrointestinal tract. Our product ranges from a disposable barium enema administration kit to advanced CT and virtual colonoscopy products. Our more...
www.ezem.com | Send Inquiry | Phone: +1-(516)-333-8230
FDA Registration: 2411512 Year Established: 1962
Products: Gastroenterologic Needle Holder (FDA Code: FHQ), X-Ray Aids, Diagnostic Aids, Biopsy Supplies, Contrast Media, Disposable Needles, ...
E-Z-EM Inc manufactures products used for imaging the gastrointestinal tract. Our product ranges from a disposable barium enema administration kit to advanced CT and virtual colonoscopy products. Our more...
Conmed Corporation | Address: 525 French Road, Utica, New York 13502, USA
www.conmed.com | Send Inquiry | Phone: +1-(315)-797-8375
FDA Registration: 1223925 Year Established: 1970 Employee Count: ~2300
Products: 80° Vertical Microscissors, AC-Powered Operating Room Table (FDA Code: FQO), AC-Powered Surgical Instrument Motor (FDA Code: GEY), Active Electrosurgical Electrode (FDA Code: FAS), AC-Powered Motor Orthopedic Surgical Instrument (FDA Code: HWE), Abdominal Trocar, ...
Conmed Corporation specializes in the fields of gastroenterology & pulmonology. Our bite block's patented integral tongue depressor offers easier esophageal intubation with direct visualization & decr more...
www.conmed.com | Send Inquiry | Phone: +1-(315)-797-8375
FDA Registration: 1223925 Year Established: 1970 Employee Count: ~2300
Products: 80° Vertical Microscissors, AC-Powered Operating Room Table (FDA Code: FQO), AC-Powered Surgical Instrument Motor (FDA Code: GEY), Active Electrosurgical Electrode (FDA Code: FAS), AC-Powered Motor Orthopedic Surgical Instrument (FDA Code: HWE), Abdominal Trocar, ...
Conmed Corporation specializes in the fields of gastroenterology & pulmonology. Our bite block's patented integral tongue depressor offers easier esophageal intubation with direct visualization & decr more...
B. Braun Medical Inc. | Address: 824 Twelfth Avenue, Bethlehem, Pennsylvania 18018-3524, USA
www.bbraunusa.com | Send Inquiry | Phone: +1-(610)-691-5400
FDA Registration: 2523676 Year Established: 1979 Annual Revenues: USD 10-25 Million Employee Count: ~600 Quality: ISO 9000, CE Certified
Products: Procedure Trays, Caps, Disposable Needles, IV Catheters & Infusion Sets, IV Sets, General Medical Supplies, ...
B. Braun Medical Inc. offers medical products. Our product categories are admixture products, dialysis products, infusion pump systems & sets, urology sets & solutions, pain control products and vascu more...
www.bbraunusa.com | Send Inquiry | Phone: +1-(610)-691-5400
FDA Registration: 2523676 Year Established: 1979 Annual Revenues: USD 10-25 Million Employee Count: ~600 Quality: ISO 9000, CE Certified
Products: Procedure Trays, Caps, Disposable Needles, IV Catheters & Infusion Sets, IV Sets, General Medical Supplies, ...
B. Braun Medical Inc. offers medical products. Our product categories are admixture products, dialysis products, infusion pump systems & sets, urology sets & solutions, pain control products and vascu more...
Aesculap Inc. | Address: 3773 Corporate Parkway, Center Valley, Pennsylvania 18034, USA
www.aesculapusa.com | Send Inquiry | Phone: +1-(800)-258-1946
FDA Registration: 2916714 Year Established: 1977 Annual Revenues: USD 1-5 Million Employee Count: ~120
Products: Curettes, Drills, Titanium Plating Systems, Suction Tubes, Dural Substitute, Posterior, ...
Aesculap Inc. manufactures surgical instrumentation. Our products include surgical instruments, laparoscopy, endoscopy, neurosurgery, sutrures, surgical quality management, and consulting services. Ou more...
www.aesculapusa.com | Send Inquiry | Phone: +1-(800)-258-1946
FDA Registration: 2916714 Year Established: 1977 Annual Revenues: USD 1-5 Million Employee Count: ~120
Products: Curettes, Drills, Titanium Plating Systems, Suction Tubes, Dural Substitute, Posterior, ...
Aesculap Inc. manufactures surgical instrumentation. Our products include surgical instruments, laparoscopy, endoscopy, neurosurgery, sutrures, surgical quality management, and consulting services. Ou more...
Surgical Specialties Corporation | Address: 100 Dennis Drive, Reading, Pennsylvania 19606, USA
Send Inquiry | Phone: +1-(610)-404-1000
Year Established: 2003 Annual Revenues: USD 10-25 Million Employee Count: ~200 Quality: ISO 9001, CE Certified
Products: Sutures, Absorbable Surgical Sutures, Dissolving Sutures, Dissolvable Sutures, Surgical Non Absorbable Sutures, Surgical Sutures, ...
Surgical Specialties Corporation provides surgeons with surgical products. We produce and distribute quill medical's self-anchoring suture technology for use in aesthetic & cosmetic surgery. We offer more...
Send Inquiry | Phone: +1-(610)-404-1000
Year Established: 2003 Annual Revenues: USD 10-25 Million Employee Count: ~200 Quality: ISO 9001, CE Certified
Products: Sutures, Absorbable Surgical Sutures, Dissolving Sutures, Dissolvable Sutures, Surgical Non Absorbable Sutures, Surgical Sutures, ...
Surgical Specialties Corporation provides surgeons with surgical products. We produce and distribute quill medical's self-anchoring suture technology for use in aesthetic & cosmetic surgery. We offer more...
Synthes, Inc. | Address: 1302 Wrights Lane East, West Chester, Pennsylvania 19380, USA
us.synthes.com | Phone: +1-(610)-719-5000, 800 523 0322
FDA Registration: 2939274
Products: Demineralized Bone Matrix, Elbow External Fixators, Hand External Fixators, Total Disc Replacements, Lumbar Total Disc Replacement, Cervical Total Disc Replacement, ...
Synthes, Inc. develops market instruments, implants and biomaterials for the surgical fixation, correction and regeneration of the skeleton and its soft tissues. We develop & market instruments, impla more...
us.synthes.com | Phone: +1-(610)-719-5000, 800 523 0322
FDA Registration: 2939274
Products: Demineralized Bone Matrix, Elbow External Fixators, Hand External Fixators, Total Disc Replacements, Lumbar Total Disc Replacement, Cervical Total Disc Replacement, ...
Synthes, Inc. develops market instruments, implants and biomaterials for the surgical fixation, correction and regeneration of the skeleton and its soft tissues. We develop & market instruments, impla more...
North American Rescue Products, Inc. | Address: 481 Garlington Road, Suite A, Greenville, South Carolina 29615, USA
www.narescue.com | Send Inquiry | Phone: +1-(864)-675-9800
FDA Registration: 3005034064
Products: Supraglotic Airway Tool (LMA, King LT), Tracheal Double, Lumen Airway, Esophageal Double,-Lumen Airway, Black Talonr Glove Kit, Trauma Shears, Laceration Repair Kit, ...
North American Rescue Products, Inc. creates and produces products that have a direct correlation to decrease preventable death on the battlefield & in training. Our product line includes pre hospital more...
www.narescue.com | Send Inquiry | Phone: +1-(864)-675-9800
FDA Registration: 3005034064
Products: Supraglotic Airway Tool (LMA, King LT), Tracheal Double, Lumen Airway, Esophageal Double,-Lumen Airway, Black Talonr Glove Kit, Trauma Shears, Laceration Repair Kit, ...
North American Rescue Products, Inc. creates and produces products that have a direct correlation to decrease preventable death on the battlefield & in training. Our product line includes pre hospital more...
Surgistar Inc. | Address: 820 Corridor Park Blvd, Knoxville, Tennessee 37932, USA
www.surgistar.com | Send Inquiry | Phone: +1-(865)-671-4300
FDA Registration: 2028661 Year Established: 1992 Annual Revenues: USD 5-10 Million Employee Count: ~40 Quality: ISO 9001 Certified
Products: Sickle Blades, MVR Blades, Trabeculectomy Blades, Neck Supplies, Blades and Knives, Tunnel Blades, Cannulas, ...
Surgistar, Inc. is a manufacturer of single use ophthalmic, ENT and surgical products. Our ophthalmology products include knives, blades, cannulas, microkeratome blades, tubing, and corneal trephines. more...
www.surgistar.com | Send Inquiry | Phone: +1-(865)-671-4300
FDA Registration: 2028661 Year Established: 1992 Annual Revenues: USD 5-10 Million Employee Count: ~40 Quality: ISO 9001 Certified
Products: Sickle Blades, MVR Blades, Trabeculectomy Blades, Neck Supplies, Blades and Knives, Tunnel Blades, Cannulas, ...
Surgistar, Inc. is a manufacturer of single use ophthalmic, ENT and surgical products. Our ophthalmology products include knives, blades, cannulas, microkeratome blades, tubing, and corneal trephines. more...
DeRoyal Industries | Address: 200 DeBusk Lane, Powell, Tennessee 37849, USA
www.deroyal.com | Send Inquiry | Phone: +1-(800)-251-9864
FDA Registration: 1048770 Year Established: 1976 Annual Revenues: USD 1-5 Million Employee Count: ~30 Quality: ISO Certified
Products: Splints, Autoclaves, Procedure Trays, Retractors, Esophageal Stethoscopes (FDA Code: BZW), Aspirators, ...
DeRoyal Industries manufactures healthcare products. Our product ranges from orthopedic hospital brands to online tools that power the medical industry. Our night splint is available with adjustable s more...
www.deroyal.com | Send Inquiry | Phone: +1-(800)-251-9864
FDA Registration: 1048770 Year Established: 1976 Annual Revenues: USD 1-5 Million Employee Count: ~30 Quality: ISO Certified
Products: Splints, Autoclaves, Procedure Trays, Retractors, Esophageal Stethoscopes (FDA Code: BZW), Aspirators, ...
DeRoyal Industries manufactures healthcare products. Our product ranges from orthopedic hospital brands to online tools that power the medical industry. Our night splint is available with adjustable s more...
Merit Medical Systems, Inc. | Address: 1600 West Merit Parkway, South Jordan, Utah 84095, USA
www.merit.com | Send Inquiry | Phone: +1-(801)-253-1600
FDA Registration: 1721504 Year Established: 1987 Annual Revenues: USD 100-500 Million Employee Count: ~1700 Quality: ISO 9001, CE Certified
Products: Cardiology Surgery Instruments, Guide Catheters, Inflation Devices, Angioplasty Accessories, Pericardiocentesis Drainage Catheters, Diagnostic Guide Wires, ...
Merit Medical Systems, Inc. manufactures medical devices used in diagnostic and interventional cardiology & radiology procedures. Our primary products are inflation devices, diagnostic and therapeutic more...
www.merit.com | Send Inquiry | Phone: +1-(801)-253-1600
FDA Registration: 1721504 Year Established: 1987 Annual Revenues: USD 100-500 Million Employee Count: ~1700 Quality: ISO 9001, CE Certified
Products: Cardiology Surgery Instruments, Guide Catheters, Inflation Devices, Angioplasty Accessories, Pericardiocentesis Drainage Catheters, Diagnostic Guide Wires, ...
Merit Medical Systems, Inc. manufactures medical devices used in diagnostic and interventional cardiology & radiology procedures. Our primary products are inflation devices, diagnostic and therapeutic more...
Allwin Medical Devices, Inc. | Address: 3305 E. Miraloma Avenue, Suite 176, Anaheim, California 92806, USA
www.allwinmedical.com | Send Inquiry | Phone: +1-(714)-572-1709
FDA Registration: 3005987240 Quality: ISO 9001, ISO 13485 Certified
Products: Grasping Forceps, Balloon Ureteral Dilators, Biliary Stents, Breast Localization Needle, Core Tissue Biopsy Needles, Fascial Dilator Set, ...
Allwin Medical Devices, Inc. manufactures urology products. Our urology products include biopsy needles, dilators, guidewires, stone buster pneumatic lithotripters, meatal dilators and urinary diversi more...
www.allwinmedical.com | Send Inquiry | Phone: +1-(714)-572-1709
FDA Registration: 3005987240 Quality: ISO 9001, ISO 13485 Certified
Products: Grasping Forceps, Balloon Ureteral Dilators, Biliary Stents, Breast Localization Needle, Core Tissue Biopsy Needles, Fascial Dilator Set, ...
Allwin Medical Devices, Inc. manufactures urology products. Our urology products include biopsy needles, dilators, guidewires, stone buster pneumatic lithotripters, meatal dilators and urinary diversi more...
Joimax, Inc. | Address: 275 E. Hacienda Avenue, Campbell, California 95008, USA
www.joimaxusa.com | Send Inquiry | Phone: +1-(408)-370-3005
FDA Registration: 3005042595
Products: Light Sources, Electrosurgical Systems, Irrigation Pumps, Disposable Surgical Instrument Kit (FDA Code: KDD), Endoscopic Surgical Light (FDA Code: FSW), Endoscopic Electrosurgical Unit and Accessories (FDA Code: KNS), ...
Joimax, Inc. deals with endoscopic spinal surgery. We offer Tessys®, video twister™, C-camsource®, jIFP 2000™, Surgimax™ and JFM 1910™. Our Tessys® spinal stenosis more...
www.joimaxusa.com | Send Inquiry | Phone: +1-(408)-370-3005
FDA Registration: 3005042595
Products: Light Sources, Electrosurgical Systems, Irrigation Pumps, Disposable Surgical Instrument Kit (FDA Code: KDD), Endoscopic Surgical Light (FDA Code: FSW), Endoscopic Electrosurgical Unit and Accessories (FDA Code: KNS), ...
Joimax, Inc. deals with endoscopic spinal surgery. We offer Tessys®, video twister™, C-camsource®, jIFP 2000™, Surgimax™ and JFM 1910™. Our Tessys® spinal stenosis more...
Alphatec Spine, Inc. | Address: 5818 El Camino Real, Carlsbad, California 92008, USA
www.alphatecspine.com | Send Inquiry | Phone: +1-(760)-431-9286, 800-922-1356
FDA Registration: 2027467
Products: Anterior Cervical Plating System, Disposable Aspiration and Injection Needle (FDA Code: GAA), Bone Fixation Nail (FDA Code: JDS), Bone Fixation Plate (FDA Code: HRS), Bone Fixation Screw (FDA Code: HWC), Cervical Intervertebral Fusion Device With Bone Graft (FDA Code: ODP), ...
Alphatec Spine, Inc. is a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spine disorders, primarily focused on the aging spine. We have more...
www.alphatecspine.com | Send Inquiry | Phone: +1-(760)-431-9286, 800-922-1356
FDA Registration: 2027467
Products: Anterior Cervical Plating System, Disposable Aspiration and Injection Needle (FDA Code: GAA), Bone Fixation Nail (FDA Code: JDS), Bone Fixation Plate (FDA Code: HRS), Bone Fixation Screw (FDA Code: HWC), Cervical Intervertebral Fusion Device With Bone Graft (FDA Code: ODP), ...
Alphatec Spine, Inc. is a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spine disorders, primarily focused on the aging spine. We have more...
CW Medical, Inc. | Address: 5595 Daniels Street, Suite E, Chino, California 91710, USA
www.cwmedical.us | Send Inquiry | Phone: +1-(909)-591-5220
Year Established: 1994 Annual Revenues: USD 1-5 Million
Products: Headrest System, Adult Tracheostomy Mask, Disposable Berman Airways, Endoscopic Electrosurgical Pencils, Disposable Nasal Oxygen Tube, Chest Roll Gel Positioners, ...
CW Medical Inc is a manufacturer and distributor of respiratory and general consumable products. Our health devices include digital dual channel TENS, mini TENS, moist heating pack, instant hand sanit more...
www.cwmedical.us | Send Inquiry | Phone: +1-(909)-591-5220
Year Established: 1994 Annual Revenues: USD 1-5 Million
Products: Headrest System, Adult Tracheostomy Mask, Disposable Berman Airways, Endoscopic Electrosurgical Pencils, Disposable Nasal Oxygen Tube, Chest Roll Gel Positioners, ...
CW Medical Inc is a manufacturer and distributor of respiratory and general consumable products. Our health devices include digital dual channel TENS, mini TENS, moist heating pack, instant hand sanit more...
Stemcor Systems, Inc. | Address: 801 Hermosa Way, Menlo Park, California 94025, USA
stemcorsystems.com | Send Inquiry | Phone: +1-(650)-3216884
Products: Bone Marrow Aspiration Needle with Adjustable Needle Stop, Disposable Aspiration and Injection Needle (FDA Code: GAA), Reusable Aspiration and Injection Needle (FDA Code: GDM), ...
Stemcor Systems, Inc. develops technologies for regenerative medicine. Our product line includes Marrowminer® and Marrowselect®. Our Marrowminer® harvests bone marrow in a minimally-invasi more...
stemcorsystems.com | Send Inquiry | Phone: +1-(650)-3216884
Products: Bone Marrow Aspiration Needle with Adjustable Needle Stop, Disposable Aspiration and Injection Needle (FDA Code: GAA), Reusable Aspiration and Injection Needle (FDA Code: GDM), ...
Stemcor Systems, Inc. develops technologies for regenerative medicine. Our product line includes Marrowminer® and Marrowselect®. Our Marrowminer® harvests bone marrow in a minimally-invasi more...
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FDA Code / Regulation: GAA / 878.4800
A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 878.9.
